NDA 19185, held by Abbott. Oxytocin.
As of Nov 13, 2026, NDA 19185 (Oxytocin 5 Usp Units In Dextrose 5%, Oxytocin 20 Usp Units In Dextrose 5%, Oxytocin 10 Usp Units In Dextrose 5%), held by Abbott, was first approved by FDA on Mar 29, 1985, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 1985 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxytocin 5 Usp Units In Dextrose 5%1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxytocin | DiscontinuedReference drug |
| Oxytocin 20 Usp Units In Dextrose 5%2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxytocin | DiscontinuedReference drug |
| Oxytocin 10 Usp Units In Dextrose 5%2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxytocin | DiscontinuedReference drug |
| Oxytocin 10 Usp Units In Dextrose 5%1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxytocin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 1986 | Supplement 4Labeling | Approved | None posted |
| Jul 1, 1985 | Supplement 1Labeling | Approved | None posted |
| Mar 29, 1985 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
